(37 days)
The HYBRID Guidewire is intended for general intravascular use, including the neuro and peripheral vasculature. The guidewire can be steered to facilitate the selective placement of diagnostic or therapeutic catheters. This device is not intended for use in the coronary arteries.
HYBRID Guidewire is a coiled wire that is designed to fit inside a percutaneous microcatheter for the purpose of directing the catheter through a blood vessel. It is used in association with catheters to enable insertion and easier navigation into the intracranial vascular branches for diagnostic or therapeutic use. Guidewires constitute an important element that conditions the success of the operation. They can be pushed and torqued to move forward through patient's tortuous anatomy.
HYBRID Guidewire consists of a proximal coated stainless steel core wire and a distal coated nitinol core wire. The distal core wire is tapered at the distal tip and is contained within a 92/8 platinum/tungsten and stainless steel coil for maximum radiopacity. The distal tip comes in various tip designs; it can be straight or curved distal tip (forming a double angle).
The coil section of the HYBRID Guidewire and the distal stainless steel section is coated with hydrophilic coating, while the proximal stainless steel section is coated with Polytetrafluoroethylene (PTFE). The purpose of the surface coatings is to provide lubricity when HYBRID Guidewire is passed through compatible microcatheters. A torquer and an introducer are also provided with the device.
The HYBRID Guidewire is a Class II device intended for general intravascular use, including neuro and peripheral vasculature, to facilitate the selective placement of diagnostic or therapeutic catheters. It is not intended for use in coronary arteries.
Here's a breakdown of the acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Visual and Dimensional Inspection | External surface free from process and surface defects; dimensions (overall length, radiopaque length, outer diameter, distal shape) per product specification. | All test samples passed testing. |
| Catheter Compatibility & Simulated Use | In vitro performance under simulated use conditions using a worst-case tortuous ICA vessel model. | All test samples passed testing. |
| Coating Integrity and Adherence | Coating quality (after dyeing and simulated use) inspected under a microscope. | All test samples passed testing. |
| Tensile Strength | Minimum force to break the guidewire meets ISO 11070. Tensile strength comparable to the predicate device. | All test samples passed testing. Tensile strength was comparable to predicate devices. |
| Corrosion Resistance | No visual evidence of corrosion after immersion in sodium chloride solution and boiling distilled/deionized water. | All test samples passed testing. |
| Torque Strength | Number of turns-to-failures comparable to the predicate device. | All test samples passed testing. The torque strength of the subject device is equivalent to the predicate device. |
| Torqueability | Rotational input to output ratio comparable to the predicate device. | All test samples passed testing. The torqueability value of the subject device is equivalent to the predicate device. |
| Fracture Resistance and Flexing Test | Resistance to damage by flexing and resistance to fracture per ISO 11070. | All test samples passed testing. |
| Tip Flexibility | Force required to deflect the distal tip (45° and 90°) comparable to the predicate device. | All test samples passed testing. The tip flexibility of the subject device is equivalent to the predicate device. |
| Particulate Matter Characterization | Particulate matter in injections quantified after simulated use comparable to the predicate device. | All test samples passed testing. Particulate matter characterization was comparable to predicate device. |
| Design Verification and Packaging Validation | Device design and packaging design meet product specification requirements at t=1 year time-point after exposure to 1x EtO sterilization. | All test samples passed testing. |
| Packaging Integrity (Visual Inspection) | Packaging free of damage; all seals free of incomplete seals, voids, channels, wrinkles, foreign material, and/or over-heated sections. Labels legible, intact, no damage or delamination. | All test samples met the acceptance criteria. |
| Packaging Integrity (Bubble Leak Test) | No leaks per ASTM F2096-11. | All test samples met the acceptance criteria. |
| Packaging Integrity (Seal Strength) | Meets seal strength per ASTM F88/F88M-15. | All test samples met the acceptance criteria. |
| Animal Testing (GLP) | In vivo performance in an acute porcine model: Trackability, handling, radiopacity, and microcatheter compatibility comparable to predicate devices. | All test samples passed testing. Trackability and handling of the guidewire, radiopacity, and compatibility with microcatheter were comparable to predicate device. |
| Biocompatibility (Cytotoxicity) | Non-cytotoxic (percent viability of test article not less than 70% compared to cells exposed to control). | The percent viability of the test article was 110.6%. Non-cytotoxic. |
| Biocompatibility (Sensitization) | Did not induce delayed sensitization. | Did not elicit sensitization response. |
| Biocompatibility (Irritation) | Non-irritant. | Non-irritant. |
| Biocompatibility (Acute Systemic Toxicity) | No evidence of significant systemic toxicity or mortality. | Non-toxic. |
| Biocompatibility (Pyrogenicity) | Non-pyrogenic (rabbit temperature rise not exceeding 0.5°C). | Non-pyrogenic. |
| Biocompatibility (Hemolysis) | Non-hemolytic (mean hemolytic index for direct contact and extract not exceeding 2%). | Non-Hemolytic. (Mean hemolytic index for direct contact was 0.71%; for extract was 0.61%). |
| Biocompatibility (Thrombogenicity) | Minimal thrombus formation; similar thromboresistance characteristics as control devices. | Passed. Minimal thrombus formation associated with test devices; neither animal's clotting abilities were compromised. Similar thromboresistance characteristics to control devices. |
| Biocompatibility (Complement Activation) | Statistically similar to negative control data. | Passed. Statistically similar to the reference negative control data (p > 0.050). |
| Biocompatibility (Partial Thromboplastin Time) | Within the same thrombogenicity category (minimal activator); responses considered similar to predicate. | Passed. Test article and predicate percent plasma control values fell within the same thrombogenicity category (minimal activator). Responses considered similar. |
| Biocompatibility (Platelet and Leukocyte Counts) | Test article comparable to reference control and comparison article (not statistically significant, p > 0.05). | Passed. Test article results for leukocyte and platelet counts showed 100.6-105.6% of negative control. Not statistically significant (p > 0.05) when compared to reference material or comparison article. Comparable to both. |
| Shelf Life (Accelerated Aging) | All acceptance criteria met at T=1 year accelerated aging, no new questions of safety or effectiveness raised. Performs as intended to Design Specification. | All acceptance criteria were met. Concluded that the HYBRID Guidewire will perform as intended to the Design Specification. Labeled for 1-year shelf life. |
| Sterilization Validation | Achieves a minimum Sterility Assurance Level (SAL) of 10-6 in accordance with ISO 11135:2007. | The validation study demonstrated that the sterilization process and equipment are capable of reliably and consistently sterilizing the devices to a minimum SAL of 10-6. Fractional cycles, half cycles, and full cycles met the acceptance criteria. |
| EO and ECH Residuals | Residual traces of Ethylene Oxide (EO) and Ethylene Chlorohydrin (ECH) below limits specified in ISO 10993-7:2008. | The residual traces of EO and ECH for the worst-case device were well below the limits specified in ISO 10993-7. |
| Bacterial Endotoxin Levels | Below 2.15 EU/device, in accordance with FDA guidance, USP <85>, and European Pharmacopeia BET 2.6.14. | < 2.15 EU/device. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the exact sample sizes for each bench test. However, it indicates "All test samples" in the results for most bench tests, implying an adequate number of samples were tested to demonstrate compliance.
For the Animal Testing (GLP), it refers to an "acute porcine model" but does not specify the number of animals used. The provenance of the data is from these controlled laboratory (preclinical) studies, as implied by "Performance Bench Testing and Animal Testing." These are prospective studies conducted specifically for regulatory submission.
For Biocompatibility testing, various in vitro and in vivo tests were performed:
- Cytotoxicity: L-929 mouse fibroblast cells.
- Sensitization: Guinea pig (not specified number but implies multiple for statistical significance).
- Irritation: Rabbits (not specified number but implies multiple for statistical significance).
- Acute Systemic Toxicity: Mice (not specified number but implies multiple for statistical significance).
- Pyrogenicity: Rabbits (not specified number but implies multiple for statistical significance).
- Hemocompatibility (Hemolysis, Thrombogenicity, Complement Activation, PTT, Platelet and Leukocyte Counts): Human blood or canine models. For thrombogenicity, it mentions "neither animal's clotting abilities," suggesting at least two animals were used, likely canine.
The provenance for biocompatibility testing is also from controlled laboratory (preclinical) studies, conducted prospectively for regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This type of information (number and qualifications of experts) is typically relevant for studies involving subjective human interpretation, such as clinical trial imaging reads or pathology reviews. For a medical device like a guidewire, the "ground truth" is established through objective, quantifiable engineering and biological tests against established standards (e.g., ISO, ASTM) and comparison to predicate devices, rather than expert consensus on individual "cases." Therefore, this section is not directly applicable to the provided data. The "experts" are implicitly the engineers and scientists conducting and analyzing these performance and biocompatibility tests according to their respective standard operating procedures and regulatory guidelines.
4. Adjudication Method for the Test Set
Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies when multiple human readers interpret data, and there's a need to resolve disagreements to establish a definitive "ground truth." Since the provided data details bench and animal testing, which rely on objective measurements and established protocols, an adjudication method in this sense is not applicable. The "adjudication" is inherent in the test methodology (e.g., meeting a specified numerical threshold, visual inspection against a clear defect standard).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This section is not applicable as the HYBRID Guidewire is a physical medical device, not an AI/Software as a Medical Device (SaMD) that involves human readers or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This section is not applicable as the HYBRID Guidewire is a physical medical device, not an AI/SaMD. The performance described is inherent to the device itself.
7. The Type of Ground Truth Used
The ground truth for the HYBRID Guidewire's performance is established by:
- Established Performance Requirements: Meeting engineering specifications that are commonly accepted for guidewires (e.g., tensile strength, torque strength, flexibility).
- International Standards: Compliance with relevant ISO (e.g., ISO 11070, ISO 10993) and ASTM standards.
- Comparison to Predicate Devices: Demonstrating that the subject device's performance is "comparable" or "equivalent" to legally marketed predicate devices, which have a history of safe and effective use.
- Biological Endpoints: For biocompatibility, the ground truth is the absence of adverse biological reactions (e.g., cytotoxicity, sensitization, irritation, pyrogenicity, significant thrombus formation, etc.) as defined by the applicable ISO 10993 standards.
8. The Sample Size for the Training Set
This section is not applicable as the HYBRID Guidewire is a physical device, not a machine learning model requiring a training set.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable as the HYBRID Guidewire is a physical device, not a machine learning model requiring a training set with established ground truth.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 4, 2018
Regulatory Technology Services LLC Mark Job Responsible Third Party Official 1394 25th Street NW Buffalo, Minnesota 55313
Re: K182337
Trade/Device Name: HYBRID Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: MOF, DQX Dated: September 25, 2018 Received: September 26, 2018
Dear Mark Job:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
{1}------------------------------------------------
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Xiaolin Zheng -S
for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K182337
Device Name HYBRID Guidewire
Indications for Use (Describe)
The HYBRID Guidewire is intended for general intravascular use, including the neuro and peripheral vasculature. The guidewire can be steered to facilitate the selective placement of diagnostic catheters. This device is not intended for use in the coronary arteries.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
HYBRID Guidewire 510(k) Summary
This 510(k) Summary for HYBRID Guidewire is submitted in accordance with the requirements of 21 CFR 807.87(h) and 807.92 and following the recommendation outlined in FDA Guidance, The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notification [510(k)], dated 28 July, 2014.
SUBMITTER [807.92(a)(1)]
Balt USA, LLC 29 Parker Irvine CA 92618
| Contact Person: | Nancy XuRegulatory Affairs Manager |
|---|---|
| Telephone: | 949-788-1443 |
| E-mail: | nancy.xu@balt-usa.com |
| Date prepared: | September 21, 2018 |
DEVICE [807.92(a)(2)]
| Name of Device: | HYBRID Guidewire |
|---|---|
| Common or Usual Name: | Guidewire |
| Classification Name: | Catheter Guide Wire |
| Product Code: | MOF |
| DQX | |
| Regulatory Class: | Class II |
| Submission Type: | Traditional 510(k) |
| Regulation Number: | 21 C.F.R. 870.1330 |
| Reviewing Product Branch: | Division of Neurological and Physical Medicine Devices (Office of |
| Device Evaluation, CDRH) |
PREDICATE DEVICE [807.92(a)(3)]
Traxcess 14 Guidewire (K133725)
REFERENCE DEVICES
Traxcess 0.007" Mini Guidewire (K161803)
Transend 300 ES Guidewire and Transend 300 Floppy Guidewire (K022357)
{4}------------------------------------------------
DEVICE DESCRIPTION [807.92(a)(4)]
HYBRID Guidewire is a coiled wire that is designed to fit inside a percutaneous microcatheter for the purpose of directing the catheter through a blood vessel. It is used in association with catheters to enable insertion and easier navigation into the intracranial vascular branches for diagnostic or therapeutic use. Guidewires constitute an important element that conditions the success of the operation. They can be pushed and torqued to move forward through patient's tortuous anatomy.
HYBRID Guidewire consists of a proximal coated stainless steel core wire and a distal coated nitinol core wire. The distal core wire is tapered at the distal tip and is contained within a 92/8 platinum/tungsten and stainless steel coil for maximum radiopacity. The distal tip comes in various tip designs; it can be straight or curved distal tip (forming a double angle).
The coil section of the HYBRID Guidewire and the distal stainless steel section is coated with hydrophilic coating, while the proximal stainless steel section is coated with Polytetrafluoroethylene (PTFE). The purpose of the surface coatings is to provide lubricity when HYBRID Guidewire is passed through compatible microcatheters. A torquer and an introducer are also provided with the device.
INDICATIONS FOR USE [807.92(a)(5)]
The HYBRID Guidewire is intended for general intravascular use, including the neuro and peripheral vasculature. The guidewire can be steered to facilitate the selective placement of diagnostic or therapeutic catheters. This device is not intended for use in the coronary arteries.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS [807.92(a)(6]]
The technological characteristics of the HYBRID Guidewire is analogous to the technological characteristics of the Traxcess 14 Guidewire (K133725), Traxcess 0.007" Mini Guidewire (K161803), and Transend 300 ES Guidewire and Transend 300 Floppy Guidewire (K022357). Substantial equivalence is determined based on the following similarities:
- similar intended use/indications for use ●
- Same principles of operation ●
- Same fundamental scientific technology ●
- Incorporate similar basic guidewire design
- Incorporate similar guidewire construction material .
{5}------------------------------------------------
Table 1 comprises the comparison between HYBRID Guidewire (Subject Device) and Traxcess 14 Guidewire (Predicate Device, K133725), Traxcess .007" Mini Guidewire (Reference Device, K161803) and Transend 300 ES Guidewire and Transend 300 Floppy Guidewire (Reference Device, K022357).
{6}------------------------------------------------
| Feature | Traxcess 14 Guidewire | Traxcess .007" MiniGuidewire | Transend 300 ES GuidewireTransend 300 FloppyGuidewire | HYBRID Guidewire | |
|---|---|---|---|---|---|
| [PREDICATE DEVICEK133725] | [REFERENCE DEVICEK161803] | [REFERENCE DEVICEK022357] | [SUBJECT DEVICE] | ||
| Product Code | MOF, DQX | MOF, DQX | DQX | Same as Traxcess .007"Mini Guidewire andTraxcess 14 Guidewire | |
| Regulatory Class | Class II | Class II | Class II | Same as Predicate Device | |
| Regulation Number | 21 CFR 870.1330 | 21 CFR 870.1330 | 21 CFR 870.1330 | Same as Predicate Device | |
| Regulation Name | Catheter Guide Wire | Catheter Guide Wire | Catheter Guide Wire | Same as Predicate Device | |
| Generic Name | Guidewire | Guidewire | Guidewire | Same as Predicate Device | |
| Indications for UseStatement | The Traxcess 14 Guidewireis intended for generalintravascular use, includingthe neuro and peripheralvasculature. The guidewirecan be steered to facilitatethe selective placement ofdiagnostic or therapeuticcatheters. This device is notintended for use incoronary arteries. | Traxcess .007" MiniGuidewire is indicated forgeneral intravascular use,including the neuro andperipheral vasculature. Theguidewire can be steered tofacilitate the selectiveplacement of diagnostic ortherapeutic catheters. Thisdevice is not intended foruse in coronary arteries. | The Transend 300 ESGuidewire and Transend 300Floppy Guidewire areintended for generalintravascular use, includingthe neuro and peripheralvasculature. The guidewirescan be torqued to facilitate theselective placement ofdiagnostic or therapeuticcatheters. These devices arenot intended for use incoronary arteries. A torquedevice (pin vise) is includedto facilitate directionalmanipulation of theguidewires. | The HYBRID Guidewireis intended for generalintravascular use,including the neuro andperipheral vasculature.The guidewire can besteered to facilitate theselective placement ofdiagnostic or therapeuticcatheters. This device isnot intended for use inthe coronary arteries. | |
| Performance | |||||
| Function | The steerable guidewire isused to facilitate theselective placement ofdiagnostic or therapeuticcatheters. | The steerable guidewire isused to facilitate theselective placement ofdiagnostic or therapeuticcatheters. | The guidewire can betorqued to facilitate theselective placement ofdiagnostic or therapeuticcatheters. | Same as Traxcess .007"Mini Guidewire andTraxcess 14 Guidewire | |
| Anatomical Location | General intravascular use,including the neuro andperipheral vasculature. | General intravascular use,including the neuro andperipheral vasculature. | General intravascular use,including the neuro andperipheral vasculature. | Same as Predicate Device | |
| Design | |||||
| Overall Length | 200 cm | 210 cm | 300 cm | 120 cm* – 310cm(*The 120 cm length devicemodel is only indicated to beused in the peripheralvasculature.) | |
| Proximal Diameter | .014" | .014" | Not Listed | .012" – .014" | |
| Distal Diameter | .012" | .007" | 0.014" minimum | .007" – .014" | |
| Core wireconfiguration | 60 cm Nitinol welded toStainless Steel | 60 cm Nitinol welded toStainless Steel | Not Listed | 40 cm – 60 cm Nitinolsoldered to Stainless Steel | |
| Coil Length | 40 cm | 6 cm | Not Listed | 8 cm or 31 cm | |
| Coil Configuration | 3 cm Platinum Nickel alloyand 37 cm Stainless Steel | 6 cm Platinum Nickel alloy | Not Listed | 3 cm of Platinum Tungstenand 27 cm stainless steelOr8 cm of Platinum Tungsten | |
| Coil Length(Radiopaque) | 3 cm | 6 cm | Not Listed | 3 cm or 8 cm | |
| Stainless Steel CoilLength | 40 cm | N/A | Not Listed | 27 cmStainless steel coil lengthnot applicable to modelswith 8cm Pt/Wconfiguration | |
| Distal Shaft Length(Shapeable Length) | 1.4 cm | 1.4 cm | Not Listed | 1.8 cm -2.0 cm | |
| Distal tip thickness(core wire) | 0.037 mm | 0.037 mm | Not Listed | 0.040 mm | |
| Docking WireCompatibility | Yes | No | Not Listed | No | |
| Material | |||||
| Proximal Core Wire | Stainless Steel | Stainless steel | Not Listed | Same as Traxcess .007"Mini Guidewire andTraxcess 14 Guidewire | |
| Distal Core Wire | Nickel titanium (Nitinol)alloy | Nickel titanium (Nitinol)alloy | Not Listed | Same as Traxcess .007"Mini Guidewire andTraxcess 14 Guidewire | |
| Coil | Platinum nickel alloy andStainless Steel | Platinum nickel alloy | Not Listed | Platinum/Tungsten andStainless Steel | |
| Coating Material | |||||
| Coil | Hydrophilic Coating[SLIP-COAT by ArgonMedical] | Hydrophilic Coating[SLIP-COAT by ArgonMedical] | Not Listed | Same as Traxcess .007"Mini Guidewire andTraxcess 14 Guidewire | |
| Distal Stainless Steel | Hydrophilic Coating[SLIP-COAT by ArgonMedical] | Hydrophilic Coating[SLIP-COAT by ArgonMedical] | Not Listed | Same as Traxcess .007"Mini Guidewire andTraxcess 14 Guidewire | |
| Proximal StainlessSteel | Hydrophilic Coating | No PTFE | Not Listed | PTFE | |
| Hydrophilic CoatingLength | Hydrophilic coating =1450 mm | Hydrophilic coating =1580 mm | Not Listed | Hydrophilic coating =9 cm -59 cmPTFE = 160 cm or 250 cm | |
| Other Attributes | |||||
| Method of supply | Sterile and single use | Sterile and single use | Not Listed | Same as Traxcess .007"Mini Guidewire andTraxcess 14 Guidewire | |
| Sterilization method | Ethylene oxide gas | Ethylene oxide gas | Not Listed | Same as Traxcess .007"Mini Guidewire andTraxcess 14 Guidewire | |
| Accessories | Shaping mandrel, Torquedevice, and Insertion Tool | Shaping mandrel, Torquedevice, and Insertion Tool | Torque Device (pin vise) | TorquerIntroducer | |
| Packageconfiguration | Placed into a Dispenserhoop, Tyvek pouch, andCarton box | Placed into a Dispenserhoop, Tyvek pouch, andCarton box | Not Listed | Same as Traxcess .007"Mini Guidewire andTraxcess 14 Guidewire |
Table 1: Predicate Devices and Reference Devices vs. Subject Device Comparison Table
{7}------------------------------------------------
{8}------------------------------------------------
{9}------------------------------------------------
{10}------------------------------------------------
{11}------------------------------------------------
PERFORMANCE DATA [807.92(b)]
Performance Bench Testing and Animal Testing: Results of the performance bench testing and animal testing (Table 2) indicate that HYBRID Guidewire (Subject Device) meets established performance requirements and is substantially equivalent for its intended use.
| Performance Bench Testing | ||
|---|---|---|
| Tests | Test Method Summary | Results |
| Visual and DimensionalInspection | Test samples were visually inspected fordamage under 2.5X magnification. Theexternal surface of the effective length ofthe guidewire shall be free from processand surface defects that could cause traumato vessels during use.Inspect dimensions for overall length,radiopaque length, outer diameter (distaland proximal), and distal shape per productspecification. | All test samples passed testing. |
| Catheter Compatibility &Simulated Use | Verify the in vitro performance ofneurovascular guidewires under simulateduse conditions using a worst case tortuousICA vessel model. | All test samples passed testing. |
| Coating Integrity andAdherence | Test samples were dyed and gone throughsimulated use testing. Inspect the coatingquality of the dyed guidewire under amicroscope. | All test samples passed testing. |
| Tensile Strength | The minimum force to break the guidewirewas tested per ISO 11070. Tensile strengthof the subject device was compared to thepredicate device. | All test samples passed testing.Tensile strength wascomparable to predicatedevices. |
| Corrosion Resistance | The test article is immersed in sodiumchloride solution before being placed in | All test samples passed testing. |
| boiling distilled or deionized water.Subsequently, the test article is examinedvisually for evidence of corrosion. | ||
| Torque Strength | Torque strength was determined by numberof turns-to-failures. Torque strength of thesubject device was compared to thepredicate device. | All test samples passed testing.The torque strength of thesubject device is equivalent tothe predicate device. |
| Torqueability | Rotational input to output ratio(torqueability value) is compared to thepredicate device. | All test samples passed testing.The torqueability value of thesubject device is equivalent tothe predicate device. |
| Fracture Resistance andFlexing Test | Testing was conducted to determine theguidewire's resistance to damage byflexing and resistance to fracture per ISO11070. | All test samples passed testing. |
| Tip Flexibility | Flexibility testing was conducted todetermine the force required to deflect thedistal tip of the guidewire when deflectedto 45° and 90°. Tip flexibility of the subjectdevice was compared to the predicatedevice. | All test samples passed testing.The tip flexibility of the subjectdevice is equivalent to thepredicate device. |
| Particulate MatterCharacterization | Particulate matter in injections of thedevice were quantified after simulated use.Particulate matter characterization of thesubject device was compared to thepredicate device. | All test samples passed testing.Particulate mattercharacterization wascomparable to predicate device. |
| Design Verification andPackaging Validation | This test is to evaluate the device designand packaging design and to demonstratethat the device will meet the productspecification requirements at t=1 year time-point after exposing to 1x EtO sterilization. | All test samples passed testing. |
Table 2: Performance Bench Testing and Animal Testing Summary
{12}------------------------------------------------
{13}------------------------------------------------
| Packaging Integrity Test | ||
|---|---|---|
| Visual Inspection | Visually inspect packaging for any signs ofdamage. All seals shall be free ofincomplete seals, voids, channels,wrinkles, foreign material in the seal and/orover heated sections. Labels shall belegible and intact, with no damage ordelamination. | All test samples met theacceptance criteria. |
| Bubble Leak Test | Perform bubble leak test per ASTMF2096-11. All samples must exhibit noleaks. | All test samples met theacceptance criteria. |
| Seal Strength | Perform seal strength test per ASTMF88/F88M-15. | All test samples met theacceptance criteria. |
| Performance Animal Testing | ||
| Animal Testing (GLP) | Animal testing is to evaluate the in vivoperformance of the device in an acuteporcine model. Trackability and handlingof the guidewire, radiopacity, andcompatibility with microcatheter wereassessed. Subject device was compared topredicate devices. | All test samples passed testing.Trackability and handling of theguidewire, radiopacity, andcompatibility withmicrocatheter were comparableto predicate device. |
Biocompatibility: Results of the biocompatibility testing (Table 3) indicate that HYBRID Guidewire (Subject Device) is biocompatible and is substantially equivalent for its intended use.
Table 3: Biocompatibility Test Summary
| Test | Results | Conclusion |
|---|---|---|
| Cytotoxicity - ISO MTSCytotoxicity Test – 24 hourExtractISO 10993-5 | The percent viability of test article is110.6%. All system suitability criteria weremet indicating a valid test assay. The fullstrength EMEM10 Test Article extract | Non-cytotoxic |
| showed no cytotoxic potential to L-929mouse fibroblast cells. | ||
| Sensitization - ISO Guinea PigMaximization Sensitization Test-(2 Extracts)ISO 10993-10 | The topical application of the 0.9% NaClextract evaluated at a concentration of 100%did not induce delayed sensitization in theguinea pig (grade 0).The topical application of the sesame oilextract evaluated at a concentration of 100%did not induce delayed sensitization in theguinea pig (grade 0). | Did not elicit sensitizationresponse |
| Irritation or Intracutaneous - ISOIntracutaneous Study in Rabbits -Two ExtractsISO 10993-10 | The 0.9% NaCl and sesame oil extracts ofthe test articles show an overall meandifference of 0. | Non-irritant |
| Acute Systemic Toxicity – ISOAcute Systemic Toxicity Study inMice - Two ExtractsISO 10993-11 | There was no evidence of significantsystemic toxicity or mortality after testarticle extracts injection. | Non-toxic |
| Systemic Toxicity –ISO Materials Mediated RabbitPyrogenISO 10993-11 | During the 3 hour observation period, noneof the rabbits administered with the testarticle extract had a temperature rise >0.5°Cat the required observation time points. Thisresponse did not exceed the USP limit andmeets the requirements for this test.Therefore, these results indicate that the testarticle was determined to be non-pyrogenic. | Non-pyrogenic |
| Hemocompatibility-Hemolysis(Direct and Indirect)ISO 10993-4 | The mean hemolytic index for the testarticle by direct contact was of 0.71%, andthe mean hemolytic index for the test articleextract was 0.61%. The direct contact of thetest article was non-hemolytic and the testarticle extract was non hemolytic. | Non-Hemolytic |
| Hemocompatibility – StandardThrombogenicity in Canine (ISO) | There was minimal thrombus formationassociated with both test devices. | Passed |
| ISO 10993-4 | Additionally, the combined analysis ofplatelet counts, device weights, and clinicalobservations indicated that neither animal'sclotting abilities were compromised afterimplantation of the devices. Based on theresults of this study, the test devices appearto have similar thromboresistancecharacteristics as the control devices. | Passed |
| Hemocompatibility -Complement Activation, SC5b-9ISO 10993-4 | The SC5b-9 assay results for thecomparison article were statistically similar( $p>0.050$ ) to the reference negative controldata; therefore, the comparison article forSC5b-9 assay is considered satisfactoryunder the test conditions employed. | Passed |
| Hemocompatibility – PartialThromboplastin Time (PTT)ISO 10993-4 | The test article and predicate percent plasmacontrol values fell within the samethrombogenicity category, minimalactivator. Within the limitations of the testsystem, the responses are consideredsimilar. | Passed |
| Hemocompatibility - Platelet andLeukocyte Counts with SponsorSupplied Comparison ArticleISO 10993-4 | The test article results for the leukocyte andplatelet counts levels showed 100.6-105.6%of the negative control. The platelet countsof the test article were not statisticallysignificant ( $p>0.05$ ) when compared to thereference material. Therefore, the test articleis comparable to the reference control. Theplatelet counts of the test article were notstatistically significant ( $p>0.05$ ) whencompared to the comparison article.Therefore, the test article is comparable tothe comparison article. | Passed |
{14}------------------------------------------------
{15}------------------------------------------------
Shelf life: The accelerated shelf life testing for HYBRID Guidewire has been conducted (T=1 years accelerated aging) with test results confirmed that all acceptance criteria were met. No new questions of safety or effectiveness are raised. Based on the results, we can conclude that HYBRID
{16}------------------------------------------------
Guidewire will perform as intended to the Design Specification. HYBRID Guidewire will be labeled for 1-year shelf life.
Packaging: The packaging validation. T=1 year accelerated aging was performed on the HYBRID Guidewire. The results from packaging testing conducted on HYBRID Guidewire showed that the acceptance criteria were met. Therefore, we can conclude the HYBRID Guidewire packaging will provide the adequate and effective protection and sterile barrier requirements.
Sterilization: HYBRID Guidewire is sterilized using 100% Ethylene Oxide (EtO) gas in the same manner as FDA cleared predicate devices, Traxcess 14 Guidewire (K133725) and Traxcess .007" Mini Guidewire (K161803). HYBRID Guidewire is sold sterile, for single use and single patient only. The sterilization validation was performed and is documented. The sterilization validation results showed that the sterilization dose and routine sterilization process was validated to achieve an SAL of 10-6 for the HYBRID Guidewire.
| Test Description | Test Summary | Results |
|---|---|---|
| Sterilization Validation | 100% EO is used to sterilizethe device to achieve aminimum SAL of 10-6. Thevalidation was conducted inaccordance with ISO11135:2007. Validation of theEO sterilization cycle wasperformed using one (1)fractional exposure cycle,four (4) half exposure cyclesand one (1) full exposurecycle, overkill approachdescribed in ISO 11135:2007Annex B. | The validation studydemonstrated that thesterilization process andequipment are capable ofreliably and consistentlysterilizing the devices to aminimum SAL of 10-6. Theappropriateness of the BI hasbeen confirmed withfractional test runs utilizingNatural Product SterilityTesting (NPRT). Fractionalcycles, half cycles, and fullcycles met the acceptancecriteria. |
| EO and ECH Residuals | EO and ECH residuals weremeasured per ISO 10993-7:2008. | The residual traces of EO andECH for the worst casedevice in the device familyafter the exposure to the EOsterilization process are well |
{17}------------------------------------------------
| below the limits specified inISO 10993-7. | ||
|---|---|---|
| Bacterial Endotoxin Levels | LAL testing was conducted inaccordance with FDAguidance document (June2012), USP<85>, andEuropean Pharmacopeia BET2.6.14 | < 2.15 EU/device |
CONCLUSIONS
The HYBRID Guidewire met all specified criteria. We conclude that the subject device, HYBRID Guidewire, is substantially equivalent in its intended use, design, material, performance, and the underlying fundamental scientific technology used, to the predicate device, Traxcess 14 Guidewire, and the reference devices, Traxcess .007" Mini Guidewire, Transend 300 ES Guidewire and Transend 300 Floppy Guidewire.
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.